Drug product
Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608
D-0330-2021
Product summary
- Event
- Event 87548
- Status
- Ongoing
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0330-2021
Official wording
Reason: Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Code information: Lot #: 20K0043P, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022
Distribution pattern: Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
Derived failure modes
-
Unknown
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.